Grastek

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Grastek

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Grastek

Quick Facts Overview

Property Description
Active Ingredient Timothygrasspollenallergen
Form Sublingual Tablet (Orally Disintegrating)
Pharmacological Class Allergen Immunotherapy (AIT)
General Purpose To induce immune tolerance to grass pollen
Origin Natural (Derived from Phleum pratense pollen)
Rx Status Prescription-only (Rx)

Grastek: Definition and Pharmacological Class

Grastek is a standardized allergen extract used as a form of Allergen Immunotherapy (AIT) for individuals sensitive to grass pollen. It is a prescription-only medicine specifically designed to address the underlying cause of the allergy, rather than just masking symptoms like sneezing or watery eyes. Products like Grastek represent an approach aimed at modifying the underlying disease mechanism.

This medication is clinically recognized for its role in long-term allergy management, working by adapting the immune system's response to specific triggers. Unlike short-term symptomatic relief medications, Grastek is aimed at achieving sustained change by systematically exposing the patient to the allergen. Its classification as a targeted immunotherapy defines its unique role in allergy management for those affected by grass pollen.


What is the Active Ingredient and Physical Form?

The active ingredient in Grastek is Timothygrasspollenallergen, a highly purified extract sourced naturally from the pollen of the Phleum pratense grass. This medicine is prepared as a small sublingual tablet that dissolves rapidly when placed under the tongue, allowing for absorption via the oral mucosa. This sublingual tablet form is intended for daily administration, differentiating it from traditional injection-based treatments.

As a single-ingredient product, it concentrates the therapeutic action specifically on the sensitivity caused by Timothy Grass, which often cross-reacts with other common grass pollens. The active extract is rigorously standardized to 2800 Bioequivalent Allergy Units (BAU), ensuring a consistent, reproducible dose necessary for safely and effectively retraining the body's immune system in individuals aged 5 through 65 years.


What is the General Purpose of Grastek?

The primary general purpose of Grastek is to achieve tolerance development, making the body less reactive to grass pollen exposure over time. It functions by employing immune system retraining through controlled, daily contact with the allergen extract. This consistent exposure initiates local and systemic immunomodulatory mechanisms that gradually shift the immune response away from a hypersensitivity reaction. The overarching benefit for the patient is a reduction in the severity of allergic symptoms, which typically occur during the grass pollen season. This method of treatment is frequently utilized when conventional pharmacotherapy provides an inadequate response.

What side effects are possible with Grastek?

Grastek: Possible Side Effects and Safety Information

Official Adverse Reaction Scope

The official regulatory safety profile for Grastek is characterized by the potential for two main types of adverse events: common, localized reactions and rare, serious systemic reactions. Adverse reactions are classified based on frequency as documented in regulatory sources.


Frequency and System-Organ Classes

The most frequently documented adverse reactions (reported in ge 5% of patients in clinical trial data) are localized to the area of administration. These include oral pruritus (mouth itching), throat irritation, ear pruritus, mouth edema, tongue pruritus, and paresthesia oral (tingling/numbness in the mouth).

These effects primarily involve the Gastrointestinal Disorders (oral symptoms), Respiratory, Thoracic, and Mediastinal Disorders (throat irritation), and Ear and Labyrinth Disorders (ear pruritus) system-organ classes.


Serious Safety Considerations and Restrictions

Official labeling includes a Boxed Warning concerning the risk of severe, life-threatening allergic reactions, such as anaphylaxis and severe laryngopharyngeal restriction (laryngeal swelling). Additionally, Eosinophilic Esophagitis has been reported as a serious adverse reaction.

Specific conditions are listed as contraindications because they may increase risk. These include a history of severe systemic allergic reaction to sublingual allergen immunotherapy, severe, unstable, or uncontrolled asthma, or a history of Eosinophilic Esophagitis.

Population and Time-Related Notes

The safety and effectiveness of Grastek are not established in patients younger than 5 years or older than 65 years. Localized allergic reactions are generally expected to be more common at the initiation of therapy. The first dose must be administered in a healthcare setting with mandatory patient observation. Furthermore, treatment should be temporarily discontinued during periods of acute oral inflammation, such as mouth ulcers or following dental surgery.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information for Grastek (Timothy Grass Pollen Allergen Extract) defines the risk of overdose primarily as the potential for an escalated, severe allergic response, rather than simple systemic toxicity.

Documented Overdose Presentations

Taking more than the prescribed daily dose may lead to an uncontrolled escalation of the medication's intended effect, resulting in severe systemic or local allergic reactions. The most serious life-threatening outcomes documented in regulatory sources are anaphylaxis and severe laryngopharyngeal restriction (throat tightness or swelling).

Manifestations requiring immediate attention include, but are not limited to:

  • Trouble breathing or throat swelling
  • Dizziness or fainting
  • Rapid or weak heartbeat
  • Severe gastrointestinal symptoms (e.g., cramps, vomiting)
  • Severe flushing or itching of the skin

Required Emergency Actions

The regulatory profile mandates specific actions in case of an overdose or severe reaction:

  1. Stop treatment immediately and cease taking Grastek.
  2. Use auto-injectable epinephrine immediately, as prescribed.
  3. Seek emergency medical treatment right away. Immediate medical attention is required upon the use of epinephrine or upon experiencing any severe allergic symptoms, as listed in the official patient information. Regulatory documents advise contacting a healthcare practitioner or hospital emergency department immediately if an overdose is suspected, even if symptoms are not yet apparent.

Therapeutic Uses of Grastek

Grastek is commonly used to help with symptomatic relief in individuals who experience allergies to Timothy grass and related cross-reactive grass pollens. The medication is intended for use in adults and children aged 5 through 65 years.

Treatment for Grass Pollen-Induced Allergic Conditions

This therapy is applied in addressing conditions involving episodic or fluctuating manifestations, namely seasonal allergic rhinitis (hay fever) and allergic conjunctivitis. It is relevant for managing symptom clusters that may become intense or disruptive, such as persistent sneezing, runny nose, nasal congestion, and the irritating, watery eyes that typically characterize moderate to severe seasonal grass allergy.

Long-Term Reduction of Seasonal Symptom Severity

Grastek is commonly used in clinical settings that involve acute or unstable symptom patterns, particularly when seasonal symptoms are difficult to manage with conventional symptom-relief medicines. This generally provides support that contributes to easing the overall symptom load throughout the entire grass pollen season.

“This therapy supports improved day-to-day comfort during periods of heightened symptoms.”

For patients who complete the full therapy cycle, this may assist with maintaining symptomatic relief during the subsequent grass pollen season. This supports patients during difficult episodes by easing distress and contributes to maintaining functional stability when symptoms are more noticeable.

Quick Fact: Supportive management for Seasonal Nasal and Ocular Discomfort

Regulatory References

  1. (https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebb02ba7-de81-4367-8ba7-d774816f85b0)

Eligibility and Restrictions for Use

Official Eligibility and Contraindications for Grastek

The regulatory profile for Grastek (Timothy Grass Pollen Allergen Extract) strictly defines the populations who may use the medicine and those who are excluded due to safety risks or lack of established data.

Approved Population Scope:

  • Age-Based Use: The medicine is approved for use in individuals 5 through 65 years of age with grass pollen-induced allergic rhinitis. Safety and effectiveness have not been established for children under 5 years or adults over 65 years.

Absolute Contraindications (Must Not Use):

  • Asthma Status: Patients with severe, unstable, or uncontrolled asthma.
  • Prior Reactions: Individuals with a history of any severe systemic allergic reaction (e.g., trouble breathing, fainting) to sublingual immunotherapy.
  • Medical Conditions: A history of eosinophilic esophagitis is a strict contraindication.
  • Allergy to Ingredients: Documented hypersensitivity to any of the inactive ingredients, such as gelatin or mannitol.

Eligibility-Related Restrictions:

  • Oral Health: Treatment must be temporarily withheld if the patient has active inflammation, mouth sores, or recent cuts in the mouth, or following dental extraction or oral surgery. Use should only resume once the oral cavity has healed.
  • Pregnancy/Lactation: Available data are insufficient to establish the presence or absence of risk during human pregnancy or breastfeeding; use is generally advised only if clearly needed.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Grastek (Timothygrasspollenallergen) primarily details constraints related to the potential need for emergency medication and restrictions tied to the sublingual route of administration.


Documented Pharmacodynamic Interactions

Since Grastek is an allergen immunotherapy that carries a risk of systemic allergic reactions, significant interactions are those that affect the required emergency treatment, epinephrine.

Interaction Entity/Substance Official Regulatory Description/Outcome
Beta-blockers (e.g., Propranolol) May render a patient unresponsive to usual doses of emergency epinephrine.
MAOIs, TCAs, Thyroid Hormone May potentiate the adverse cardiovascular effects of emergency epinephrine.
Other Allergen Immunotherapy Contraindicated combination; increases the likelihood of systemic or local adverse reactions.

Administration and Timing Constraints

Conventional pharmacokinetic interactions (e.g., CYP or transporter-mediated) are not documented, as regulatory sources indicate no specific interaction studies have been conducted on the allergen extract itself. The key constraints relate to the site of absorption.

  • Food or Beverage: Administration must be separated in time. Patients must avoid eating or drinking for at least 5 minutes following the sublingual dose.
  • Oral Wounds/Inflammation: Treatment must be stopped to allow the oral cavity (e.g., sites of dental extraction, mouth ulcers) to completely heal to prevent potential excessive local reactions or systemic exposure.

Mechanism of Action

Grastek is an allergenic extract derived from Timothy grass pollen (Phleum pratense). Administered to the oral mucosa, it interacts directly with antigen-presenting cells (APCs), such as dendritic cells, within the sublingual lymphoid tissue. This interaction initiates immunomodulation, a type of specific immunotherapy.

The mechanism involves shifting the immune response away from a T-helper 2 (TH2) cell-dominant profile, characterized by Immunoglobulin E (IgE) and mast cell activation, toward a TH1 and regulatory T-cell (Treg) profile. This shift is mediated by the induction of Treg cells, which produce immunosuppressive cytokines, primarily Interleukin-10 (IL-10) and Transforming Growth Factor-beta (TGF-beta).

Downstream, IL-10 acts as a negative regulator, suppressing TH2 cytokine production (e.g., IL-4 and IL-5) and promoting B-cell class switching to produce blocking antibodies, specifically Immunoglobulin G4 (IgG4). The increased systemic levels of allergen-specific IgG4 function as competitive antagonists, binding to the grass pollen allergen and preventing its interaction with pre-existing, cell-bound IgE on mast cells and basophils. This process culminates in a systemic reduction of allergen-induced inflammatory cell degranulation and subsequent mediator release upon subsequent environmental exposure.

Dosage and Administration Information

How to Use Grastek: Official Administration Guidelines

Grastek is administered daily as a fixed-dose 2800 BAU sublingual tablet, representing a standardized regimen without dose titration for individuals aged 5 through 65 years. The treatment protocol defines specific conditions for initiation and duration.


Administration Scope

Instruction Category Official Requirement
Route of Administration Sublingual use only (placed under the tongue).
Dosing Schedule One tablet of 2800 BAU once daily (qDay).
Age-Group Rules Same dose for children 5 years of age and older. Children must be supervised by an adult.
Treatment Timing Initiate at least 12 weeks before the expected start of the grass pollen season.
Duration Daily use throughout the grass pollen season, with the option for up to 3 consecutive years for sustained effect.
Missed Dose Rule If interrupted for more than 7 days, consult a clinician before restarting. Do not double the dose.

Administration Procedure

Proper use of the sublingual tablet is governed by key procedural steps to ensure appropriate absorption via the oral mucosa.

  1. Handling: Remove the tablet from the blister pack using dry hands and place it immediately under the tongue.
  2. Dissolution: Allow the tablet to dissolve completely.
  3. Swallowing Restriction: Refrain from swallowing for at least 1 minute after placement.
  4. Food/Drink Restriction: Avoid consuming food or beverages for a minimum of 5 minutes after taking the tablet.

Furthermore, the initial dose is mandated to be administered in a healthcare setting under the supervision of a physician, followed by an observation period of at least 30 minutes, with subsequent doses taken at home.

Recent Clinical Evidence

Grastek (Timothy Grass Pollen Allergen Extract) is an FDA-approved sublingual tablet for immunotherapy used to treat grass pollen-induced allergic rhinitis, with or without conjunctivitis, in individuals aged 5 through 65. Clinical studies have provided robust data on its efficacy and safety profile.

Efficacy Across Seasons

The treatment's effectiveness is primarily measured by reductions in the Total Combined Score (TCS), which aggregates daily symptom scores and rescue allergy medication usage. Major trials have consistently demonstrated that Grastek significantly reduces both nasal and ocular symptoms throughout the grass pollen season compared to a placebo. This benefit is particularly notable during the peak grass pollen season, where symptom and medication reductions tend to be highest. Participants typically begin treatment approximately 12 weeks before the expected onset of the pollen season and continue daily throughout the season.

Sustained Treatment Effect

Long-term data supports a sustained benefit following extended treatment. In one five-year study, patients who received the daily tablet for three consecutive years showed a continued decrease in grass allergy symptoms. This therapeutic effect persisted throughout the first full grass pollen season following the discontinuation of the treatment. This evidence suggests that a multi-year course of sublingual immunotherapy may alter the underlying allergic response, providing relief even after active treatment has ceased.

Safety Profile Overview

Grastek is generally well-tolerated, with most adverse reactions being localized and mild-to-moderate. The most frequently reported side effects are associated with the mouth and throat, as summarized in the table below. Serious systemic allergic reactions, including anaphylaxis, are possible but uncommon, which is why the first dose is administered under the supervision of a healthcare professional.

Adverse Reaction Grastek Group (%)† Placebo Group (%)†
Oral pruritus (mouth itching) 24–27% 2–4%
Throat irritation 21–23% 2–3%
Mouth edema (swelling) 10–11% <1%
Ear pruritus (ear itching) 7–13% 1%

Figures based on pooled data from major clinical trials.

Discontinuation due to adverse reactions occurred in a small percentage of patients (around 5%) across clinical trials, emphasizing the importance of monitoring and patient education on managing local reactions.

Frequently Asked Questions (FAQ)

Common questions about Grastek (FAQ)


Q: Is Grastek the same kind of treatment as allergy shots?

Grastek is a type of Allergen Immunotherapy (AIT) called Sublingual Immunotherapy (SLIT) because it is a tablet dissolved under the tongue. Traditional allergy shots, or Subcutaneous Immunotherapy (SCIT), are another method of AIT. Regulatory information indicates that Grastek is not to be taken in combination with other forms of allergen immunotherapy, as this may increase the likelihood of experiencing adverse reactions.


Q: Does Grastek contain any food allergens like nuts or gluten?

Official product documents list the active ingredient (Timothy Grass Pollen) and inactive ingredients (excipients), including fish gelatin, mannitol, and sodium hydroxide. While the official ingredient list does not specifically mention or exclude nuts or gluten, if a patient has known hypersensitivity to any of the ingredients, a discussion with a healthcare provider is noted.


Q: Is Grastek a cure for grass pollen allergy?

Regulatory documents classify Grastek as an immunotherapy intended to treat grass pollen-induced allergic rhinitis. This type of treatment is designed to induce immune tolerance over time and is not intended for the immediate relief of symptoms. Clinical studies focused on demonstrating its ability to reduce symptoms and the need for relief medications during the grass pollen season.


Q: Can Grastek be used to treat severe asthma?

No. Official product documents state that Grastek is contraindicated (must not be used) in patients with severe, unstable, or uncontrolled asthma. It is indicated for allergic rhinitis (hay fever) with or without eye symptoms in certain eligible patients.


Q: What are the most common reasons a doctor would prescribe Grastek?

Grastek is officially indicated for treating grass pollen-induced allergic rhinitis (hay fever), which may include conjunctivitis (allergic eye symptoms). It is typically prescribed after testing confirms a sensitivity to Timothy grass pollen or cross-reactive grass pollens. It may be considered for patients whose symptoms are not adequately controlled by standard allergy medications like antihistamines or nasal sprays.


Q: How quickly does Grastek start to have an effect?

Grastek is not intended for the immediate relief of allergic symptoms, as it is a long-term immunotherapy treatment. Official administration guidelines state that treatment should be initiated at least 12 weeks before the start of the expected grass pollen season. Clinical studies evaluated effectiveness based on results measured over the course of an entire pollen season, as it is not for immediate relief.


Q: Are there any drug interactions with common cold medicines and Grastek?

The official prescribing information lists specific interactions with certain drugs, such as beta-blockers and some antidepressants, that could interfere with emergency allergic treatment. General cold medicines like decongestants are not typically listed as specific pharmacodynamic interactions in the regulatory documents, though reviewing all current medications with a healthcare provider is part of managing treatment.


Q: Is Grastek available in generic form?

Grastek is currently only available as the brand-name product. According to official drug registers, no generic equivalent of this standardized allergenic extract has been approved at this time.


Q: Is Grastek considered a biologic drug?

Grastek is classified by regulatory authorities as a standardized allergen extract product. Because it is derived from a natural source (Timothy grass pollen) and works by modulating the immune system, it is regulated by the FDA’s Center for Biologics Evaluation and Research (CBER) in the United States.


Q: Are there special monitoring requirements for children taking Grastek?

Yes, there are specific administration requirements for children. Official regulatory documents require that children must be supervised by an adult when taking the tablet daily. The very first dose must also be administered in a healthcare setting under the observation of a physician, a rule that applies to all patients regardless of age.


Q: Does Grastek stop working if you stop taking it suddenly?

Official guidance addresses interruptions in treatment, noting that if the daily tablet is stopped for more than seven days, a healthcare provider should be consulted before resuming. Evidence from clinical studies showed that after taking the tablet for three full years, the therapeutic benefit was sustained throughout the next grass pollen season, even after discontinuation.


Q: Is Grastek only prescribed by specialists?

Official labeling indicates that the first dose of Grastek should be administered by a physician in a healthcare setting. Regulatory sources note that the prescribing clinician should have adequate training and experience in managing allergic diseases, which often points toward an allergist or similarly trained specialist.


Q: Are there any specific lifestyle changes needed while on Grastek?

Yes, there are specific rules related to administration and oral health. Patients must avoid eating or drinking for at least five minutes after placing the tablet under the tongue. Treatment must also be temporarily stopped if a patient has any inflammation, sores, or cuts in the mouth, or following dental surgery, and should only resume once the mouth has fully healed.


Q: Are there warnings about Grastek and dental procedures?

Yes. Official safety information indicates that Grastek treatment must be temporarily withheld following any major dental procedure, such as a dental extraction or oral surgery. Treatment should also be stopped if you have mouth sores or cuts, and only resumed once the oral cavity has completely healed.


Q: What is the main goal of treatment with Grastek?

The main goal, as described in official labeling, is to provide immunotherapy for grass pollen-induced allergic rhinitis. This is intended to address the underlying allergic cause, resulting in a reduction in symptoms and lessening the patient's need for symptom-relieving allergy medications during the grass pollen season.


Q: Does Grastek protect against all types of grass pollen?

The active ingredient in Grastek is derived specifically from Timothy grass pollen. Official indications state that it is used for patients confirmed to be allergic to Timothy grass or other grass pollens that are known to cross-react with Timothy grass, which includes several common types like perennial rye and Kentucky blue grass.


Q: Can Grastek be used by someone who is pregnant or breastfeeding?

According to official product information, the available human data are insufficient to definitively establish the presence or absence of risk during pregnancy or breastfeeding. Use during these periods is generally advised only if clearly needed. A healthcare provider should evaluate the potential benefits and risks before starting or continuing treatment, as data is limited.


Q: What happens if I forget to swallow the tablet right away?

The official administration instructions require patients to keep the tablet under the tongue and refrain from swallowing for at least one minute to ensure proper absorption. Regulatory documents do not specifically detail the consequences if the tablet is swallowed immediately, but following the one-minute restriction is required for appropriate use.


Q: Can I stop taking my antihistamines once I start Grastek?

Clinical studies evaluated the benefit of Grastek by measuring the reduction in the use of allergy symptom-relieving medications like antihistamines. Official product information confirms this potential reduction, but adjustments to existing allergy medication are managed by a clinician, as official product information does not provide specific advice on when to stop or continue.


Q: Does Grastek affect the results of a blood test?

The way Grastek works is by changing the immune response, which includes increasing the levels of certain substances in the blood, such as allergen-specific IgG4 antibodies. While these changes can be measured in specialized blood tests, official information does not indicate that Grastek interferes with general blood chemistry or standard diagnostic blood tests.


Q: Do studies show if Grastek is more effective for some patients than others?

Regulatory documents summarize the clinical trials by showing the overall effectiveness of Grastek across the general study population, which included adults and children within the approved age range. The official prescribing information does not provide specific subgroup comparisons regarding whether the treatment is significantly more or less effective for one particular group of patients compared to another.

How should Grastek be stored and disposed of?

Storage and Disposal of Grastek


Official Storage Requirements

Grastek must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F), with excursions allowed up to 30 C. The sublingual tablets must be kept in their original container to protect from moisture.

Handling and Child Safety

Handling the tablet requires dry hands before placing it under the tongue. Grastek must always be stored out of the reach of children; adult supervision is necessary for administration to children.

Disposal Instructions

Unused or expired medication must not be thrown away via household waste or wastewater. Disposal must follow local waste management regulations or specific local requirements for the proper disposal of pharmaceuticals.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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